Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

CORD, LLC

Status: Terminated

Conditions: Cataract

Treatments: Device: Model LI61SE; Device: Model SC9

Study type: Interventional

Funder types: Industry

Identifiers

NCT03179397

SC9-0015

Details and patient eligibility

About

To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.

Full description

Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb).

Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects).

Subjects will be followed for 36 Months.

Enrollment: 338 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts
• Able to comprehend and sign a statement of informed consent
• Willing and able to complete all required postoperative visits
• Calculated Lens Power within the available range for the study IOL's
• Planned cataract removal by phacoemulsification
• Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes
• Subjects with less than 1.0D of corneal astigmatism
• Clear intraocular media other than cataract in the study eye
• Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare
• Pupil size greater or equal to 6.0mm after dilation

Exclusion criteria

• Any corneal abnormality, other than regular corneal astigmatism
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32)
• Previous refractive surgery
• Amblyopia
• Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
• Diabetic retinopathy
• Extremely shallow anterior chamber, not due to swollen cataract
• Microphthalmos
• Previous retinal detachment
• Previous corneal surgery
• Recurrent severe anterior or posterior segment inflammation of unknown etiology
• Rubella or traumatic cataract
• Iris Neovascularization
• Glaucoma (uncontrolled or controlled with medication)
• Aniridia
• Optic nerve atrophy
• Damaged incomplete zonules
• Systemic disease that could increase the operative risk or confound the outcome
• Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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338 participants in 2 patient groups

Model SC9

Experimental group

Description:

Investigational IOL

Treatment:

Device: Model SC9

Model LI61SE

Active Comparator group

Description:

FDA Approved IOL

Treatment:

Device: Model LI61SE